Ultrasound Effects on Glycemic Control in T2DM

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT05354947
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Ultrasound Delivery — DEVICE
    A General Electric LOGIQ E10 ultrasound machine with a C1-6-XD clear probe, will be used to selectively deliver pulsed ultrasound to both, the portal region of the liver and the superior mesenteric plexus.

Study Details

This is an open label, exploratory pilot study that will assess the effects of dual site focused pulsed ultrasound treatment on glycemic parameters in subjects with T2DM.

Key Dates

Start date
Nov 1, 2022
Status verified
Jan 2026
Primary completion
May 31, 2026
Completion
May 31, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 30 minute, dual site stimulation
    Ultrasound Deliveryfor 30 minutes total: 15 minutes on the liver target site and 15 minutes on the intestinal target site.
  • Experimental: 60 minute, dual site stimulation
    Ultrasound Delivery for 60 minutes total: 30 minutes on the liver target site and 30 minutes on the intestinal target site.

Primary Outcome Measure

Number of Hepatic Adverse Events - Elevation of liver transaminases AST / ALT. [ Time Frame: 2 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Yale-New Haven HospitalNew HavenConnecticut06510
Alice Hahn
475-321-0504
Raimund Herzog, MD (PRINCIPAL_INVESTIGATOR)

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